MAJOR ONGOING INITIATIVES

Intellectual Property Rights

The new CTEP IP Option was implemented on April 1, 2011 following a Federal Register announcement and public comment period initiated in April 2010. Following review and consideration of all of the comments received, the Division formed a committee with representatives from NCI technology transfer, Office of General Council (OGC) and Office of Technology Transfer (OTT) to finalize the language. The new IP Option offers commercial NERFs (non-exclusive, royalty-free) licenses to a narrow scope of inventions that claim the use and/or composition of the agent provided and, for the first time, addresses inventions related to agent-treated human samples or clinical data from patients treated with the agent on a clinical trial (biomarker inventions). For biomarker inventions, the collaborator receives a research NERF along with a NERF to disclose the inventions in support of regulatory filings to support a marketing application and to disclose on the product insert or promotional materials following regulatory approval. For all types of inventions, the institutions retain the ability to practice the invention for academic purposes. (For complete details, refer to: http://ctep.cancer.gov/industryCollaborations2/default.htm#guidelines_for_collaborations.)